SVN53-67/M57-KLH Peptide Vaccine in Treating Patients With Newly Diagnosed Multiple Myeloma Receiving Lenalidomide Maintenance Therapy

PRIMARY OBJECTIVES:

I. To determine the toxicity profile of the SVN53-67/M57-KLH peptide (SVN53-67/M57-KLH
peptide vaccine) in Montanide ISA 51 (incomplete Freund's adjuvant) plus GM-CSF
(sargramostim) (vaccine), given before or after the start of lenalidomide maintenance in
patients with multiple myeloma.

SECONDARY OBJECTIVES:

I. To measure the immune responses induced by SVN53-67/M57-KLH with Montanide ISA 51 plus
GM-CSF, either alone or with lenalidomide maintenance added either before or after the
vaccine.

TERTIARY OBJECTIVES:

I. To collect preliminary data on therapeutic efficacy of this combination against multiple
myeloma, including response rate, time to progression and disease progression slope.

II. To test if human leukocyte antigen (HLA) types and survivin positivity affect the immune
responses induced by SVN53-67/M57-KLH with Montanide ISA 51 plus GM-CSF.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP A: Patients receive SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant
subcutaneously (SC) and sargramostim SC every 2 weeks at weeks 0, 2, 4, and 6 for up to 4
doses and then receive a booster in week 12. Beginning in week 4, patients receive
lenalidomide maintenance therapy orally (PO) once daily (QD) in the absence of disease
progression or unacceptable toxicity.

GROUP B: Patients receive SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant SC
and sargramostim SC every 2 weeks at weeks 4, 6, 8, and 10 for up to 4 doses and then receive
a booster in week 16. Beginning in week 0, patients receive lenalidomide maintenance therapy
PO QD in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 16, 20, and 24 weeks and
then every 3 months for up to 5 years.

Inclusion Criteria:

- Understand and voluntarily sign an informed consent form

- Able to adhere to the study visit schedule and other protocol requirements

- Patients with newly diagnosed multiple myeloma who have at least a partial response
after induction therapy based on the International Working Group (IWG) Uniform
Response Criteria

- Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 at study entry

- Must be free of systemic infection; subjects with active infections (whether or not
they require antibiotic therapy) may be eligible after complete resolution of the
infection; subjects on antibiotic therapy must be off antibiotics for at least 7 days
before beginning treatment

- Absolute neutrophil count >= 750/mm^3

- Platelet count >= 30,000/mm^3

- Creatinine clearance >= 30 mL/minutes

- Total bilirubin =< 2 mg/dL

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and
alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x
upper limit of normal (ULN)

- All study participants must be registered into the mandatory Revlimid Risk Evaluation
and Mitigation Strategy (REMS)®, and be willing and able to comply with the
requirements of the Revlimid REMS®

- Females of reproductive potential must adhere to the scheduled pregnancy testing as
required in the Revlimid REMS® program

- Able to take aspirin (81 or 325 mg) daily for prophylactic anticoagulation (patients
intolerant to acetylsalicylic acid, ASA, may use warfarin or low molecular weight
heparin or other anticoagulants as deemed appropriate by physician)

- Disease free of prior malignancies for > 2 years with exception of currently treated
basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma "in situ" of
the cervix or breast

- All study participants must have one of the HLA alleles: HLA-A*02, HLA-A*03, HLAA*11,
or HLA-A*24

Exclusion Criteria:

- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form

- Pregnant or breast feeding females; (lactating females must agree not to breast feed
while taking lenalidomide)

- Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study as determined by the Principal
Investigator

- Chemotherapy, immunotherapy, radiotherapy, radiosurgery, interferon (e.g. Intron-A®),
allergy desensitization injections, growth factors (e.g. Procrit®, Aranesp®,
Neulasta®), interleukins (e.g. Proleukin®) or any investigational therapeutic
medication within 4 weeks of study entry

- Known hypersensitivity to thalidomide, lenalidomide, Keyhole Limpet Hemocyanin (KLH),
or granulocyte colony-macrophage stimulating factor (GM-CSF)

- The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs

- Known seropositive for or active viral infection with human immunodeficiency virus
(HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); patients who are
seropositive because of hepatitis B virus vaccine are eligible

- Any prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy or
autoimmune disorders with visceral involvement

- Patients with a known diagnosis of plasma cell leukemia

- Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent per day at study
entry

- Patients had prior autologous or allogeneic stem cell transplant; prior stem cell
collection is allowed

- Life expectancy less than 4 months